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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: LCP PROXIMAL TIBIAL PLATE PLATE, FIXATION, BONE

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SYNTHES GMBH UNK - PLATES: LCP PROXIMAL TIBIAL PLATE PLATE, FIXATION, BONE Back to Search Results
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/07/2021
Event Type  malfunction  
Manufacturer Narrative
This report is for an unk - plates: lcp proximal tibial plate/unknown lot. Part and lot numbers are unknown, udi number is unknown. Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent open reduction internal fixation surgery for tibial plateau fracture with the locking screw in question and a plate. When the surgeon inserted the locking screw to a combi-hole of a plate, the locking screw didn¿t lock and penetrated the plate. The surgeon removed the locking screw and inserted another locking screw of the same size instead. It locked properly. The surgery was completed successfully without any surgical delay. This report is for one (1) unk - plates: lcp proximal tibial plate. This is report 2 of 2 for complaint (b)(4).
 
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Brand NameUNK - PLATES: LCP PROXIMAL TIBIAL PLATE
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK SYNTHES UMKIRCH (DE)
im kirchenhürstle 4-6
umkirch bei freiburg 79224
GM 79224
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12084555
MDR Text Key258920441
Report Number8030965-2021-05405
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 06/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/29/2021 Patient Sequence Number: 1
Treatment
UNK - SCREWS: NAIL PROXIMAL LOCKING
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